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Mechanisms of Mindfulness-based Interventions

Mechanisms of Mindfulness-Based Interventions (MBIs)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03571386
Acronym
MBI
Enrollment
136
Registered
2018-06-27
Start date
2019-01-08
Completion date
2022-09-30
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety, Stress

Keywords

Mindfulness, Depression, Anxiety, stress

Brief summary

Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes.

Detailed description

The state of mindfulness can be described as a form of meta-awareness in which attention is allocated to the present moment of external and internal sensory or mental experience, without reactivity, and without dwelling on any particular sensory or mental object with judgement or evaluation. Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. Empirically supported MBIs include acceptance and commitment therapy (ACT; Hayes, Strosahl, & Wilson, 1999), dialectical behavior therapy (DBT; Linehan, 1993), mindfulness-based cognitive therapy (MBCT; Segal, Williams, & Teasdale, 2002), and mindfulness-based stress reduction (MBSR; Kabat-Zinn, 1982, 1990). Variations on these approaches, including integration of mindfulness training into individual psychotherapy from diverse perspectives, also have been described (Germer, Siegel, & Fulton, 2005). As the empirical evidence for the efficacy of these interventions continues to grow, the importance of investigating the mechanisms or processes by which they lead to beneficial outcomes is increasingly recognized. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes. Target (mechanism) engagement is expected to facilitate identification of individuals who are most likely to benefit (or not) from MBIs and further develop targeted interventions for optimization of delivery. Although there are very specific aims and hypotheses to be tested, this preliminary exploratory investigation will provide feasibility data and allow for refining existing hypotheses for larger research proposals to be submitted for extramural grant support.

Interventions

Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed

BEHAVIORALMindfulness-based Stress Reduction (MBSR)

Standardized 8-week patient-centered educational approach which uses relatively intensive training in core meditation practices that teaches people how to take better care of themselves using mindfulness skills and live healthier and more adaptive lives.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Across all ARMS: * At prescreen, must be currently registered for MBCT or MBSR; at posttest, must have attended five of eight sessions for completion. * Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions * Age range: 18-55 * Right-handed * If currently taking maintenance anti-depressant and/or anti-anxiety medication, must have a stable regimen as indexed by no medication or dosage changes within the past three months * No prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder * No current history (\< 6 months) of substance abuse/dependence * No current history (\< 6 months) of regular meditation practice (\>1 session/week; \>10 min/session) * No history of medical illness associated with possible changes in cerebral tissue or cerebrovasculature or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes) * No current suicidal ideation Eligibility for Depression & Anxiety Cohort: Depression * Reports having been diagnosed with non-psychotic unipolar major depressive disorder (MDD) * ≥3 previous episodes of MDD * Beck Depression Inventory-II (BDI-II) score between 14 and 28 (an indicator of depressive symptoms of mild to moderate severity) * No fMRI contraindications: pregnancy, claustrophobia, or presence of a ferromagnetic object, including orthodontic braces Anxiety: * Reports having been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, panic disorder, specific phobia) * Score of ≥40 on the Trait subscale of the Spielberger State-Trait Anxiety Inventory (an indicator of anxious symptoms of moderate to high severity) Eligibility for High Stress Cohort: \- Reports of High Stress as measured by perceived Stress Scale Eligibility for Drawing Blood: * At least 110 pounds * Not pregnant * Generally healthy by self-report (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no symptoms of a heart condition within six months prior to collection, no known sickle cell disease) * Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL * No more than one blood draw will have occurred during the preceding week

Design outcomes

Primary

MeasureTime frameDescription
Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word StimuliBaseline to 12 weeksfMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.

Secondary

MeasureTime frameDescription
Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTBaseline to 12 weeks (pre- to post-MBCT)P1 Evoked event-related electrical potentials (ERP) amplitudes elicited from specific emotional threat vs. neutral stimuli were primary outcome. An 80-150 ms search window at EEG electrode P8 was used to identify the P1 peak, & mean value around peaks (50 ms) was exported for analysis. Mean P1-Cue amplitudes were analyzed pre- to post-MBCT to determine the effects of time (pre to post-MBCT), emotion (angry vs. happy), and congruency (congruent vs. incongruent). Mean P1-Cue amplitudes in microvolts and SD for each condition are summarized below.
Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskBaseline to ~12 weeksEffects of time (pre-MBCT versus post-MBCT), emotion (angry versus happy), and congruency (congruent probes versus incongruent probes) on reaction time (RT) was measured in mild to moderate depression/anxiety group.

Other

MeasureTime frameDescription
Self-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness TrainingBaseline to ~12 weeks pre- to post-MBCT (depression/anxiety cohort)The Depression & Anxiety Stress Scale (DASS-Anxiety) (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.
Self-report Psychological Measures of Stress Pre- to Post-Mindfulness TrainingBaseline to ~12 weeks pre- to post-MBSR (high stress cohort)The Perceived Stress Scale (PSS-14) is a 14-item scale, with a total range from 0 (no symptoms) to 56 (highest severity) Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

Countries

United States

Participant flow

Recruitment details

Recruitment lasted through In-person and virtual 8-week MBCT courses were held in a group format with approximately 12 participants in each in-person group and 20 participants in each virtual group. Participants were recruited from the greater Nashville community through ResearchMatch, and the Osher Center for Integrative Medicine at Vanderbilt.

Participants by arm

ArmCount
Mild to Moderate Depression and/or Anxiety
Patients who currently have mild to moderate severity of depression and/or anxiety symptoms are who are receiving Mindfulness-Based Cognitive Therapy (MBCT) in a group setting as standard of care will be recruited for this arm. Mindfulness-based Cognitive Therapy (MBCT): Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed
69
High Stress
Patients with a history of reported stress who are receiving Mindfulness-Based Stress Reduction (MBSR) in a group setting as standard of care will be recruited for this study. All patients are eligible. Mindfulness-based Stress Reduction (MBSR): Standardized 8-week patient-centered educational approach which uses relatively intensive training in core meditation practices that teaches people how to take better care of themselves using mindfulness skills and live healthier and more adaptive lives.
67
Total136

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyscheduling conflict40
Overall StudyWithdrawal by Subject155

Baseline characteristics

CharacteristicMild to Moderate Depression and/or AnxietyHigh StressTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
69 Participants67 Participants136 Participants
Age, Continuous32 years
STANDARD_DEVIATION 10
44 years
STANDARD_DEVIATION 10
38 years
STANDARD_DEVIATION 8
Race/Ethnicity, Customized
Asian
3 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Black/African American
5 Participants9 Participants14 Participants
Race/Ethnicity, Customized
More Than One Race
3 Participants5 Participants8 Participants
Race/Ethnicity, Customized
White
58 Participants52 Participants110 Participants
Region of Enrollment
United States
69 participants67 participants136 participants
Sex: Female, Male
Female
39 Participants56 Participants95 Participants
Sex: Female, Male
Male
30 Participants11 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 690 / 67
other
Total, other adverse events
0 / 690 / 67
serious
Total, serious adverse events
0 / 690 / 67

Outcome results

Primary

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli

fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.

Time frame: Baseline to 12 weeks

Population: Only 16 participants in Mild to moderate depression and/or anxiety participated in fMRI data collection. Participants in the High Stress Arm/Group were not assessed using fMRI and the subgroup was smaller given financial constraints.

ArmMeasureGroupValue (MEAN)Dispersion
Mild to Moderate Depression and/or AnxietyChange in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word StimuliBOLD - Right Frontopolar Cortex |2.315 units on a scaleStandard Error 0.5
Mild to Moderate Depression and/or AnxietyChange in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word StimuliBOLD - Right Dorsolateral PFC |2.13 units on a scaleStandard Error 0.5
Mild to Moderate Depression and/or AnxietyChange in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word StimuliBOLD - Left Precuneus |-2.255 units on a scaleStandard Error 0.5
Secondary

Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT

P1 Evoked event-related electrical potentials (ERP) amplitudes elicited from specific emotional threat vs. neutral stimuli were primary outcome. An 80-150 ms search window at EEG electrode P8 was used to identify the P1 peak, & mean value around peaks (50 ms) was exported for analysis. Mean P1-Cue amplitudes were analyzed pre- to post-MBCT to determine the effects of time (pre to post-MBCT), emotion (angry vs. happy), and congruency (congruent vs. incongruent). Mean P1-Cue amplitudes in microvolts and SD for each condition are summarized below.

Time frame: Baseline to 12 weeks (pre- to post-MBCT)

Population: only depression/anxiety cohorts participated in ERP analyses. High stress group was not analyzed using ERP analyses

ArmMeasureGroupValue (MEAN)Dispersion
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Cues pre-MBCT2.62 mean amplitude in microvolts & SDStandard Deviation 2.83
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Cues post-MBCT2.60 mean amplitude in microvolts & SDStandard Deviation 2.74
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Cues pre-MBCT2.68 mean amplitude in microvolts & SDStandard Deviation 2.81
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Cues post-MBCT2.58 mean amplitude in microvolts & SDStandard Deviation 2.73
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Congruent Cues pre-MBCT1.19 mean amplitude in microvolts & SDStandard Deviation 2.32
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Congruent Cues post-MBCT.87 mean amplitude in microvolts & SDStandard Deviation 1.97
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Incongruent Cues pre-MBCT1.16 mean amplitude in microvolts & SDStandard Deviation 2.3
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Angry Incongruent Cues post-MBCT.61 mean amplitude in microvolts & SDStandard Deviation 2.24
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Congruent Cues pre-MBCT1.19 mean amplitude in microvolts & SDStandard Deviation 2.42
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Congruent Cues post-MBCT.64 mean amplitude in microvolts & SDStandard Deviation 2.22
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Incongruent Cues pre-MBCT1.14 mean amplitude in microvolts & SDStandard Deviation 2.15
Mild to Moderate Depression and/or AnxietyAmplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCTMean amplitude (uv) and standard deviations for Happy Incongruent Cues post-MBCT.65 mean amplitude in microvolts & SDStandard Deviation 2.11
Secondary

Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task

Effects of time (pre-MBCT versus post-MBCT), emotion (angry versus happy), and congruency (congruent probes versus incongruent probes) on reaction time (RT) was measured in mild to moderate depression/anxiety group.

Time frame: Baseline to ~12 weeks

Population: Only Mild to moderate depression and/or anxiety cohort who completed MBCT was analyzed for the dot-probe task. Data for this assessment was not collected from participants in the High Stress Arm

ArmMeasureGroupValue (MEAN)Dispersion
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes congruent with angry emotional stimuli pre-MBCT | unit of measure: mean RT & SE)303.50 millisecondsStandard Error 1.2
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes incongruent with happy emotional stimuli pre-MBCT | unit of measure: mean RT & SE304.22 millisecondsStandard Error 1.2
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes congruent with angry emotional stimuli post-MBCT | unit of measure: mean RT & SE298.30 millisecondsStandard Error 1.2
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes incongruent with angry emotional stimuli pre-MBCT | unit of measure: mean RT & SE304.51 millisecondsStandard Error 1.3
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes incongruent with angry emotional stimuli post-MBCT | unit of measure: mean RT & SE301.29 millisecondsStandard Error 1.5
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes congruent with happy emotional stimuli pre-MBCT | unit of measure: mean RT & SE301.47 millisecondsStandard Error 1.4
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes congruent with happy emotional stimuli post-MBCT | unit of measure: mean RT & SE297.5 millisecondsStandard Error 1.3
Mild to Moderate Depression and/or AnxietyResponse Time to Probes as a Function of Emotion and Congruency in the Dot Probe TaskRT to probes incongruent with happy emotional stimuli post-MBCT | unit of measure: mean RT & SE301.38 millisecondsStandard Error 1.1
Other Pre-specified

Self-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness Training

The Depression & Anxiety Stress Scale (DASS-Anxiety) (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

Time frame: Baseline to ~12 weeks pre- to post-MBCT (depression/anxiety cohort)

Population: Only 50 of the Depression and anxiety cohort who completed MBCT were tested on DASS-Anxiety and DASS-Depression pre/post MBCT; High Stress cohort was tested using the Perceived Stress Scale and reported in other outcomes

ArmMeasureGroupValue (MEAN)Dispersion
Mild to Moderate Depression and/or AnxietySelf-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness TrainingDASS-D scores pre- to post-MBCT | Mean change scores, (SE)7.96 Score on a scaleStandard Error 1.41
Mild to Moderate Depression and/or AnxietySelf-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness TrainingDASS-A mean change pre- to post-MBCT | mean change, (SE)3.68 Score on a scaleStandard Error 1.28
Other Pre-specified

Self-report Psychological Measures of Stress Pre- to Post-Mindfulness Training

The Perceived Stress Scale (PSS-14) is a 14-item scale, with a total range from 0 (no symptoms) to 56 (highest severity) Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

Time frame: Baseline to ~12 weeks pre- to post-MBSR (high stress cohort)

Population: Only the High Stress cohort was tested using the Perceived Stress Scale (PSS-14); Depression and anxiety cohort was tested on DASS-Anxiety and DASS-Depression and reported in other outcomes

ArmMeasureValue (MEAN)Dispersion
High StressSelf-report Psychological Measures of Stress Pre- to Post-Mindfulness Training-7.4 Score on a scaleStandard Error 2.3

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026